FDA 510(k) clearance: Needle-type epilators

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FDA 510(k) clearances: Needle epilators

Beginning on 28 May 1976, the US Food and Drug Administration (FDA) began requiring new medical devices to demonstrate they were "substantially equivalent" to a product marketed before 1976.

On 16 January 1996, FDA reclassified needle epilators and no longer requires them to submit 510(k) data.

See FDA needle reclassification

FDA classifies needle epilators and accessories as follows:

• Device Classification Name: Epilator, needle-type
• Regulation Number: 878.5350
• Product Code: KCW

Product Code KCW

Needle epilators and accessories cleared by FDA, 1976-1996

Note: Any needle epilator marketed since 16 January 1996 will not be listed below, but that does not mean that the device is any more or less safe or effective than devices that were required to get clearance.

^[1] The D'Plume XXII device currently marketed is not a needle epilator, but a photoepilator.

^[2] The Berkowits device currently marketed is not a needle epilator, but an electric tweezer.

Sources:

Releasable 510(k) Database (type in KCW under Product Code to list all needle epilator and accessory clearances)